External fixation

ABSTRACT

An orthopedic external fixation system may include a distal bar having a curvature that varies along its length, an uncurved proximal bar, a plurality of proximal embedding members, and a plurality of distal embedding members. The proximal and the distal embedding members, sized and shaped for embedding in bone, may attach directly or indirectly to the proximal bar and the distal bar, respectively.

SUMMARY

An orthopedic external fixation system may include a distal bar having acurvature that varies along its length, an uncurved proximal bar, aplurality of proximal embedding members, and a plurality of distalembedding members. The proximal and the distal embedding members, sizedand shaped for embedding in bone, may attach directly or indirectly tothe proximal bar and the distal bar, respectively.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of an embodiment of an externalfixation system.

FIG. 2 shows an embodiment of a distal bar having an uncurved portionand a curved portion following the curvature of a noncircular ellipse.

FIG. 3 shows an embodiment of a distal bar having an uncurved portionand a semicircular curved portion, with a plurality of distal embeddingmembers extending from the distal bar into bone.

FIG. 4 shows an exemplary use of an embodiment illustrated in FIG. 1with a plurality of distal embedding members extending from the distalbar into bone.

FIGS. 5-6 show perspective view and a side view, respectively, of aproximal embedding member connector.

FIGS. 7-9 illustrate perspective, a front view of an unlockedconfiguration, and a front view of a locked configuration, respectively,of a distal embedding member connector.

FIG. 10 illustrates connector motions along a distal bar.

FIG. 11 illustrates various degrees of freedom in an embodiment of anexternal fixation system.

FIG. 12 shows an embodiment with a distal bar having multiple linearsegments.

DETAILED DESCRIPTION

An external fixation system is used to stabilize fractured bonefragments in a relative alignment that facilitates bone healing. Anexternal fixation system typically includes a number of pins, wires,and/or screws percutaneously inserted into bone fragments and clamped toone or more anchoring bars or rods. In the case of nonbridging externalfixation of a distal radius fracture, a proximal bar may be fixed to theradius proximal to the fracture by threaded pins or screws, and a distalbar may be fixed to one or more fragments of the radius, distal to thefracture, by K-wires. The distal bar, or a portion thereof, may becurved, as described in more detail below. Fracture stability isachieved by insertion of K-wires, along one or more planes, into thedistal bone fragment(s) and attaching the K-wires to the distal bar. Thedistal bar is then connected to the proximal bar.

FIG. 1 shows a perspective view of an external fixation system 10 havinga distal bar 14, an uncurved proximal bar 12, and a plurality ofproximal embedding members 16 (“proximal pins”) and proximal embeddingmember connectors 24. A plurality of the proximal pins 16 may be fixedto the arm of a patient and connected to the proximal bar 12 to serve asan anchor for the external fixation system 10. The proximal embeddingmember connectors 24 may be positioned along the length of the uncurvedproximal bar 12 to anchor the proximal pins 16 appropriately. Theproximal bar may optionally have detents or other surface features thatmate with a proximal embedding member to define preferred connectionpositions. The proximal embedding member connectors 24 can be clamped atvarious positions along the length of the proximal pin 16.

A plurality of proximal embedding members 16 may be attachable to theproximal bar 12 directly or indirectly. Direct attachment between theproximal embedding member and the proximal bar may involve the twocomponents making contact with one another. For example, a proximal barmay have holes sized and shaped to receive a proximal embedding memberby press-fit. Holes in the proximal bar may be threaded to receivecomplementary threads on proximal embedding members. Direct attachmentmay also be accomplished by the proximal bar having a built-in clamp orother mechanisms to connect the proximal embedding member to theproximal bar without the need for an intermediate component. A proximalembedding member may also be glued to a proximal bar for directattachment.

Indirect attachment between the proximal embedding member 16 and theproximal bar 12 may include an intermediate clamp to which bothcomponents are connected. For example, FIG. 1 shows a plurality of aproximal embedding member connectors 24 connecting a proximal embeddingmembers to a proximal bar.

Distal embedding members 23 may be attachable to a distal bar 14directly or indirectly in the various ways described above for proximalembedding members and a proximal bar.

The proximal bar may be fixed relative to the patient's forearm byattaching it to the radius with at least two pins/screws, typicallypositioned at least several centimeters apart from one another along thelength of the proximal bar. When so attached, the proximal bar istypically oriented so that it runs parallel to the shaft of the radius,with respect to both the pitch of the bar and its medial/lateral skewwith respect to the shaft of the radius, but nonparallel orientations,in pitch and/or skew, are also possible.

A proximal embedding member connector 24 may also connect the distal bar14 to the uncurved proximal bar 12. FIG. 1 is an illustration of onepossible attachment point between the distal bar 14 and the proximaluncurved bar 12. The distal bar 14 may be attached at different pointsalong the length of the proximal uncurved bar 12.

The distal bar 14 has an uncurved portion 26 and a curved portion 27 andlies in a plane transverse (such as perpendicular or oblique) to theproximal bar. The curved portion may curve in a plane transverse to theproximal bar. A plurality of distal embedding member connectors 22 mayconnect and fix distal embedding members (such as K-wires, not shown) tothe distal bar. Proximal and distal embedding members may includeradioopaque features to facilitate radiographic confirmation of properplacement.

The proximal and distal bars may have a variety of shapes and sizes. Itmay have a circular cross-section, round cross-section, ellipticalcross-section, polygonal cross-section, and/or square cross-section. Ifthe cross-section has flat sides, the edges defining the sides may berounded. A bar may have a diameter in the range of about 1 mm to about12 mm, about 3 mm to about 11 mm, about 3 mm, about 4 mm, about 5 mm,about 8 mm, and/or about 11 mm. The diameter of a bar may be constantalong the length of the bar or may vary. (If the bar has other than acircular cross-section, the “diameter” refers to the longest segmentthat can be obtained by joining two points at the edge of thecross-section.) A bar may be solid or hollow inside. A bar may have alength in the range of about 3 cm to about 30 cm.

The proximal and distal bars may be made of a wide variety of materials.The bars may be made, in whole or in part, from carbon fiber, metal,stainless steel, titanium, aluminum (such as grades 6061 and 7075),plastic, polysulfone, polyether sulfone (such as RADEL®-A plasticresin), polyphenylsulfone (such as RADEL®-R plastic resin), amongothers. A bar may be radiolucent. A bar may be of unitary construction(i.e., is formed from a single piece of material, without any joints orconnections) or may be formed by joining two or more pieces together.

The length of the uncurved portion 26 of the distal bar may be in therange of about 4 centimeters to about 6 centimeters. The curved portion27 of the distal bar may curve through an arc of at least 45 degrees, atleast 60 degrees, at least 90 degrees, between about 90 degrees andabout 180 degrees, about 180 degrees, and/or at least 180 degrees. Thecurved portion 27 of the distal bar 14 may have a constant curvature ora nonconstant curvature. A nonconstant curvature may follow a sector of,for example, a noncircular ellipse, a hyperellipse, a hypoellipse, anoval, a parabola, a hyperbola, or an involute, among other shapes. Thedistal bar 14 may have a first portion having a first curvature and asecond portion having a second curvature which is different from thefirst curvature.

One or more curved portions of the distal bar 14 may follow a sector ofa circle. The distal bar 14 may curve through at least ⅛ of thecircumference of a circle, at least ⅙ of the circumference of a circle,at least ¼ of the circumference of a circle, between ¼ and ½ of thecircumference of a circle, about ½ of the circumference of a circle,and/or at least ½ of the circumference of a circle. The circle that thedistal bar curved portion follows may have a radius in the range ofabout 0.5 inches to about 5 inches, about 1 inch to about 2 inches,about 1 inch, exactly 1 inch, about 1.5 inches, exactly 1.5 inches,about 2 inches, and/or exactly 2 inches.

One or more curved portions of the distal bar 14 may follow thecurvature of a noncircular ellipse. The distal bar 14 may follow thecurvature of an ellipse having a major axis of about 7 cm in length anda minor axis of about 5 cm in length. The distal bar 14 may follow thecurvature of an ellipse having a major axis of about 6 cm in length anda minor axis of about 4 cm in length. Alternatively, the distal bar 14may follow the curvature of an ellipse having an eccentricity in therange of about 0.5 to about 0.8, about 0.6 to about 0.8, and/or about0.69 to about 0.75. (Eccentricity of an ellipse is an unitless quantitythat indicates deviation from a circular shape and is defined to equal√{square root over (1−(b²/a²))}, where a and b are the major and minoraxes, respectively, of the ellipse. A circle has an eccentricity of zeroand a noncircular ellipse has an eccentricity that is greater than zerobut less than one. The eccentricity of an ellipse that reasonablyapproximates the cross-section of a human wrist typically falls in therange of about 0.6 to about 0.8. The eccentricity of an ellipse thatreasonably approximates the cross-section of a human finger typicallyfalls in the range of about 0.5 to about 0.6.) The distal bar 14 maycurve through at least ⅛ of the circumference of an ellipse, at least ⅙of the circumference of an ellipse, at least ¼ of the circumference ofan ellipse, between ¼ and ½ of the circumference of an ellipse, about ½of the circumference of an ellipse, and/or at least ½ of thecircumference of an ellipse.

The distal bar 14 may be positioned on the skin or with space between itand the patient's skin to allow for postoperative swelling. The distalbar may be spaced apart from the skin at distance in the range of 0 cmto about 3 cm, 0 cm to about 2 cm, 0 cm to about 1.5 cm, about 1 cm toabout 1.5 cm, and/or about 0.5 cm to 1.5 cm. For example, the distal barmay be designed to follow a curve appropriately larger than the relevantportion of the patient's anatomy. If no swelling is expected, then a barthat contacts or lies within a few millimeters of the skin may be usedto provide a low-profile fixation system.

FIG. 2 shows an embodiment of a distal bar. In the depicted embodiment,the distal bar 14 has a curved portion 27 and an uncurved portion 26.The curved portion extends from one end of the uncurved portion andfollows an elliptical curve through somewhat more than ¼ of thecircumference of the ellipse. The ellipse that the curved portionfollows has major and minor axes that exceed the major and minor axes, aand b, respectively, of the depicted ellipse that approximates thecross-section of the anatomy about which the bar is positioned (such asthe forearm in the vicinity of the distal radius).

FIG. 3 depicts another embodiment of a distal bar. In this embodiment,the curved portion has a constant curvature (i.e., it is circular) andcurves through an arc of 180 degrees (i.e., it has a semicircularshape). This distal bar may be termed a “J-bar” in view of its shape.FIG. 3 also depicts an exemplary use of the distal bar. Each of aplurality of distal embedding members 23 (such as K-wires) extend fromthe distal bar into a bone fragment F. The distal embedding members maybe so oriented and positioned relative to one another that they form a“subchondral scaffold” of wires that support the fragment in one or moreplanes. The distal embedding members may also be oriented to cross thefracture lines.

In one exemplary use shown in FIG. 4, the system is used in the repairof a distal radius fracture. In such a scenario, the curved portion 27of the distal bar 14 may be sized an shaped so that it wraps around thepatient's distal forearm on the radial (anatomically lateral) side. Theproximal bar is fixed to the shaft of the radius with pins andconnectors. The distal bar is fixed to the proximal bar by a connector.A plurality of K-wires are fixed to the distal bar by connectors andembedded in the distal radius fragments. The curved portion of thedistal bar permits placement of the K-wires at a wide variety of anglesfrom several positions around the distal radius without the need to bendor otherwise distort the wires. Using unbent K-wires helps minimizewobble, shift, torque, and shear stress. The K-wires may, however, bebent and still provide enough support if proper placement into thedistal fragment requires it.

FIGS. 5 and 6 illustrate an embodiment of a proximal embedding memberconnector 24 having two grooved blocks 32. The blocks may be identicalto one another. The block defines a groove, such as C-shaped groove. Inthe depicted embodiment, the blocks define C-shaped grooves 34 that areoriented perpendicular to one another. The two blocks 32 may be orientedat other angles with respect to each other, so that the grooves 34 maybe oriented in a wide range of angles depending on a patient's need. Thegrooves may be sized and shaped to receive the uncurved proximal bar 12and/or the proximal pins 16. Once a desired position of the proximalembedding member connectors 24 is obtained, a locking screw 30 maysimultaneously lock the two C-groove blocks 32 to each other and fix thelocked blocks to the uncurved proximal bar 12 as shown in FIG. 1. Bytightening the screw, the clamping force is applied and two blocks 32will come together until they contact one another. FIG. 6 represents anembodiment of an unlocked configuration of a proximal embedding memberconnector 24.

FIGS. 7-9 show various views of an exemplary embodiment of a distalembedding member connector 22. The depicted embodiment includes aC-groove block 47 and J-block 48, each having a groove to receive adistal bar 14 and a distal embedding member 20, respectively. FIG. 8illustrates the exemplary distal embedding member connector in anunlocked configuration. As for the proximal embedding member connector,a locking screw (not shown) may bring the J-block 48 and the C-grooveblock 47 until they contact one another to secure the distal embeddingmember 20 to the distal embedding member connector 22 and fix theposition of the distal member connector 22 with respect to the distalbar 14. Distal embedding member connectors 22 may be positioned alongthe length of the uncurved portion of the distal bar 14 as shown in FIG.1.

Distal embedding member connectors 22 may slide and/or rotate along andwith respect to the distal bar (FIG. 10) These motions, taken with otherpossible adjustments (shown in FIG. 11), illustrate the various ways bywhich the distal bar position and orientation may be controlled.

The C-shaped groove 44 and the through hole 46 may be connected by av-shaped cutout 44 as shown in FIG. 8. The v-shaped cutout or othersimilar shapes that have a decreasing width may facilitate clamping ofthe distal embedding member connector 22 by providing initial resistanceto connection that abruptly gives way with a click to provide audibleand tactile confirmation of correct positioning.

Some or all portions of the proximal and/or distal embedding memberconnectors may be made with radiolucent material such as carbon fiber.

FIG. 12 shows a distal bar 50 for an external fixation system having aplurality of linear segments 52 bent at angles relative to one another.The distal bar 50 may have one, two, three, four, five, six, or morelinear segments. Adjacent linear segments 52 may extend relative to oneanother at an angle α in the range of about 5 degrees to about 20degrees, separately for each occurrence. The distal embedding memberconnectors 22 as shown in FIG. 1 may be used in this configuration tosecure the distal embedding members 20 to the linear segments 52. Insome embodiments, there may be a single linear segment 52 which mayextend from the rest of the bar at a variety of angle. If that singlelinear segment extends at an angle of or about 90 degrees, then the barmay be termed an “L-bar.”

As discussed previously, external fixation systems described herein maybe used to provide non-bridging fixation for fractures of the distalradius. They may also be used to provide spanning fixation and/ordistraction across a distal radius fracture and/or across one or morebones of the carpus. The disclosed external fixation systems may also beused in treating fractures of other bones, such as metacarpals,phalanges in hands or feet, ulna, humerus, clavicle, scapula, the bonypelvis, femur, tibia, fibula, bones of the ankle, and/or metatarsals.

1-32. (canceled)
 33. An external fixation system comprising: a distalbar having a curvature varying along its length; an uncurved proximalbar; a plurality of proximal embedding members attachable directly orindirectly to the proximal bar and sized and shaped for embedding inbone; a plurality of distal embedding members shaped for embedding inbone; and a plurality of distal embedding member connectors movablealong the distal bar so that at least one distal embedding memberconnector may be interconnected to a distal embedding member and whereinat least a portion of each distal embedding member connector defines (i)a groove sized to receive the distal bar and (ii) a through-hole sizedto receive a distal embedding member, the at least one distal embeddingmember connector including: a first block defining a first hole adjacentto a side surface of the first block and a cutout extending along alength of the side surface and connected to the first hole, the cutouthaving a decreasing width, the first hole sized and configured toreceive the distal bar therein, a second block including a second holesized and configured to receive one of the plurality of distal embeddingmembers therein, and a locking screw configured to couple the firstblock to the second block.
 34. An orthopedic external fixation systemaccording to claim 33 wherein said distal bar comprises a plurality oflinear segments bent at angles relative to one another.
 35. Anorthopedic external fixation system according to claim 33 wherein saiddistal bar comprises an uncurved portion having zero curvature; and acurved portion having a curvature that approximates the curvature of anoncircular ellipse.
 36. An orthopedic external fixation systemaccording to claim 35 wherein the uncurved portion of the distal bar hasa length in the range of about 4 to about 6 centimeters.
 37. Anorthopedic external fixation system according to claim 35 wherein thecurved portion of the distal bar curves through an arc of no less than45 degrees.
 38. An orthopedic external fixation system according toclaim 37 wherein the curved portion of the distal bar curves through anarc of at least 60 degrees.
 39. An orthopedic external fixation systemaccording to claim 37 wherein the curved portion of the distal barcurves through an arc of at least 90 degrees.
 40. An orthopedic externalfixation system according to claim 37 wherein the curved portion of thedistal bar curves through an arc of between about 90 degrees and about180 degrees.
 41. An orthopedic external fixation system according toclaim 37 wherein the curved portion of the distal bar curves through anarc of about 180 degrees.
 42. An orthopedic external fixation systemaccording to claim 37 wherein the curved portion of the distal barcurves through an arc of at least 180 degrees.
 43. An orthopedicexternal fixation system according to claim 37 wherein the curvature ofthe curved portion is defined by a constant radius of curvature.
 44. Anorthopedic external fixation system according to claim 37 wherein thecurvature of the curved portion is defined by a variable radius ofcurvature.
 45. An orthopedic external fixation system according to claim33 wherein the distal bar comprises a first portion having a firstcurvature and a second portion having a second curvature different fromthe first curvature.
 46. An orthopedic external fixation systemaccording to claim 33 wherein the curvature of distal bar is defined bya noncircular ellipse.
 47. An orthopedic external fixation systemaccording to claim 33 wherein the curvature of distal bar is defined byan ellipse having a major axis of about 7 cm in length and a minor axisof about 5 cm in length.
 48. An orthopedic external fixation systemaccording to claim 33 wherein the curvature of distal bar is defined byan ellipse having an eccentricity in the range of about 0.6 to about0.8.
 49. An orthopedic external fixation system according to claim 33wherein the curvature of distal bar is defined by an ellipse having aneccentricity in the range of about 0.69 to about 0.75.
 50. An orthopedicexternal fixation system according to claim 33 wherein the curvature ofthe distal bar curves through at least ⅛ of the circumference of theellipse.
 51. An orthopedic external fixation system according to claim33 wherein the curvature of the distal bar curves through at least ⅙ ofthe circumference of the ellipse.
 52. An orthopedic external fixationsystem according to claim 33 wherein the curvature of the distal barcurves through at least ¼ of the circumference of the ellipse.
 53. Anorthopedic external fixation system according to claim 33 wherein thecurvature of the distal bar curves through between about ¼ and ½ of thecircumference of the ellipse.
 54. An orthopedic external fixation systemaccording to claim 33 wherein the curvature of the distal bar curvesthrough about ½ of the circumference of the ellipse.
 55. An orthopedicexternal fixation system according to claim 33 wherein the curvature ofthe distal bar curves through at least ½ of the circumference of theellipse.
 56. An orthopedic external fixation system according to claim33 wherein the distal bar defines a plurality of through holes.
 57. Anorthopedic external fixation system according to claim 33 wherein thedistal bar is made at least in part of carbon fiber.
 58. An orthopedicexternal fixation system according to claim 33 wherein the distalembedding members comprise K-wires.
 59. An orthopedic external fixationsystem according to claim 33 wherein the distal bar includes at leastthree linear segments.
 60. An orthopedic external fixation systemaccording to claim 34 wherein adjacent segments are bent at angles inthe range of about 5 degrees to about 20 degrees relative to oneanother.